Pharmaceutical Jobs in this Week – 21.5.2012

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Pharmacovigilance Jobs:

 

 

Pharmaceutical Jobs - CK ClinicalMedical Writing Jobs:

Regulatory Affairs Jobs:

 

Clinical Jobs:

Pre-Clinical Jobs:

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Pfizer submit plans for $129M expansion in Belgium

Fierce Pharma Manufacturing reported that Pfizer may be planning a $129 million expansion at its manufacturing campus in Puurs, Belgium, which is to be announced next week.

Paul Schoeters of the Christian trade union ACV said that plans for a new manufacturing plant and packaging line have been submitted to the works council. He says about 100 new jobs are anticipated to be created due to the expansion.

The union rep also said “This is a crucial investment if one considers the economic climate. It indicates America’s confidence in Puurs and serves as a tremendous boost for employees here,’

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GSK gets approval from FDA for Acne treatment

Pharmatimes reported that GlaxoSmithKline‘s acne treatment Fabior foam has been given approval by regulators in the USA.

The US Food and Drug Administration has approved GSK unit Stiefel’s Fabior (tazarotene) foam. It is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients 12 years of age and older

Acne is the most common skin problem in the US, affecting about 40 – 50 million Americans at any one time. Therefore this is welcome news for those who suffer with the condition.

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Senior Clinical Study Manager Job in London, UK

Russell Oakley at CK Clinical is currently recruiting for a Senior Clinical Study Manager to join a global pharmaceutical manufacturer based in London, UK on a permanent basis.

The company:

This client is a global pharmaceutical manufacturer involved in the development of pharmaceuticals in the therapeutic areas of oncology, diabetes, cardiovascular and hypertension.

Senior Clinical Study Manager Job Description:

As Senior Clinical Study Manager, you will be responsible for  the execution of Phase II and Phase III oncology studies according to ICH guidelines in support of the clinical strategies defined in the Integrated Development Plan (IDP) as they relate to European specific responsibilities. Support of Phase I trials may also be required.

You will be a key member of the oncology clinical team responsible for conducting clinical studies, which includes participating in writing of study protocols; total management of assigned study conduct, including oversight of the study team and CROs/other vendors; identifying and resolving study site issues; managing the study budget and study closeout with a focus on European activities

As Senior Clinical Study Manager, you may also be required to participate in the training of more junior members of staff.

The role will be based in central London but will involve international travel as well as work centred in the UK.

Qualifications, Skills and Experience:

The ideal candidate for this Senior Clinical Study Manager, you will have the following qualifications, skills and experience:

  • Bachelors Degree preferably in Life Sciences, or R.N., or international equivalent.
  • Demonstrable clinical trial management experience including accumulation of one year of monitoring experience required.
  • Demonstrated ability to manage multiple clinical trials on time and within budget.
  • Superior communication skills: written, oral, interpersonal and presentation.
  • Excellent problem solving and analytical skills.
  • Must work effectively in a cross-cultural matrix team environment and be flexible to contribute to the needs of the group.
  • Clear, direct, tactful communication skills are required.
  • Good writing skills with experience in writing study protocols, summaries, clinical brochures, FDA annual reports and other clinical documents for submission to the FDA. Writing should be clear, concise and accurately represent findings.
  • Strategic thinking – Begin to participate in strategic planning. Able to anticipate potential problems and obstacles and plan accordingly.
  • Ability to organize and manage a CRO and multiple sites participating in a clinical trial.
  • Ability to prioritize work effectively to meet timelines.
  • Demonstrates professional and effective presentation skills.
  • Analytical skills – ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
  • Responsible for resolving issues with study conduct with appropriate staff, CRO and study sites for a clinical study.
  • Solid judgment is required before applying the solutions program wide.
  • Good judgment, professionalism and independence are needed in interfacing with staff, CROs, study coordinators, and investigators Interpersonal Flexibility – ability to adapt to other personalities and cultural differences, in a respectful manner that is conducive to goal achievement
  • Resource Management – ability to manage internal and external vendor resources related to study trial conduct.

The following skills are not essential but would be desirable for this Senior Clinical Study Manager position:

  • In depth knowledge of oncology clinical trials.
  • Familiarity with MS Outlook, Word, Excel, etc.
  • Participation in NDA/CTD process

How to apply:

Russell Oakley - Senior Consultant at CK Clinical
Please contact Russell for more details.

Click here to apply online now.

For more information regarding this Senior Clinical Study Manager job in London, please contact Russell Oakley at CK Clinical on +44 (0) 114 283 9956 or email roakley@ckscience.co.uk. Please quote reference CL24219 in all correspondence.

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Medical Information Associate – Surrey

Mylene Paumier at CK Clinical is recruiting for a Medical Information Associate to join a global pharmaceutical company at their site based in Surrey on a 7 months contract basis.

Responsibilities:

As Medical Information Associate the main purpose of your role will be to:

  • Provide technical and medical information with high quality customer service
  • Research and prepare responses for escalated medical inquiries as well as Scientific Response Documents related to one or two therapeutic areas
  • Researching and responding to inquiries received via phone, email, internet or mail
  • Document the inquiry and response accurately and completely according to relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
  • Identifying and recording, adverse events and product quality complaints as well as processing fulfilment
  • Exhibiting broad knowledge of assigned therapeutic area and a solid understanding of pertinent disease state(s)
  • Handling escalated MI inquiries from various sources
  • Creating and maintaining MI documents by ensuring that responses are medically and scientifically accurate, timely, balanced, and meet customers’ needs
  • Ensuring the alignment of response documents to global/regional/local labelling and licensing for all the Countries we support.
  • Maintain compliance with corporate and departmental training, SOPs and WIs.

Qualifications and skills:

The successful candidate for this Medical Information Associate will have the following qualifications, skills and experience:

  • Bachelor’s degree in a science/health-related field (Pharmacy Degree Preferred)
  • Some Pharmacy/Hospital experience preferred
  • Medical Information/Pharmaceutical experience preferred
  • High level of Proficiency in both written and spoken English and one or more of the following languages: Norwegian, Danish, Finnish, Swedish, German or French
  • Proficiency with computer and software applications (Microsoft Office)

This position may require the position holder  to work occasional bank holidays and to work hours outside of the normal local working hours.

How to apply:

Apply online:

For more information or to apply for this Medical Information Associate position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk.  Please quote reference CL24240 in all correspondence

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Hub Labelling Manager – Surrey

Shreeya Patel at CK Clinical is recruiting for a Hub Labelling Manager to join a global pharmaceutical company at their Surrey site on a 12 month contract.

Responsibilities:

The Hub Labelling Manager is responsible for executing the content management of local product documents regardless of registration procedure. As Hub Labelling Manager you will keep up to date with regional labelling regulations. The role will also oversee content across all labels for their assigned products in their assigned regions and be consistent wherever possible.

As Hub Labelling Manager you will be reporting into the locally based Regional Labelling Team Leader. The Hub Labelling Manager will be expected to utilize regulatory expertise to review, develop and deliver core labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.

Qualifications and skills:

As Hub Labelling Manager you must be able to demonstrate the ability to interpret and apply regional/local regulatory guidance around labelling and associated supportive documentation, both pre and post approval. You must also have a proven strength in logical, analytical and writing ability with complete fluency in the English language.

How to apply:

Apply online:

For more information or to apply for this Hub Labelling Manager position please contact Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk.  Please quote reference number CL24249 in all correspondence.

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Discovery of new treatment for pancreatic cancer

As reported by the BBC, Cancer Research funded scientists have identified a previously unknown faulty gene that appears to play a key role in some aggressive forms of pancreatic cancer.

A study published in the journal Nature, showed that a gene was being switched off in the cancerous cells. Scientists from Cancer Research UK’s Cambridge Research Institute and the Wellcome Trust Sanger Institute said drugs were already being tested which had the potential to turn the gene back on, to stop the spread of the cancer.

Currently around 8000 people in the UK are diagnosed with pancreatic cancer every year and fewer than one in five patients survive their disease for a year or more

Dr Julie Sharp, Cancer Research UK’s senior science information manager, said: “These results raise the possibility that a class of promising new cancer drugs may be effective at treating some pancreatic cancers.”

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Our Latest Clinical Jobs in this Week – 30/04/2012

Here is a list of the latest  clinical jobs that the Consultants here at CK Clinical have had in this week:

Clinical Project Physician – Oncology – South East

Regulatory Affairs Manager – Home Counties

Team Lead Pharmacovigilance Physician – South East

Director Clinical Developemnt – Oncology – South East

Head Of Medical Affairs – Surrey

Project Coordinator – Medical Affairs – Berkshire

Senior Pharmacovigilance Executive – Buckinghamshire

CRA Manager for Eastern Europe – Home Counties

Director of Regulatory Affairs – London

Clinical Project Physician – Oncology – Buckinghamshire

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Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to confidentially discuss your requirements and any relevant pharmaceutical jobs we are recruiting for.

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Senior Pharmacovigilance Executive Buckinghamshire

Hendre Moolman at CK Clinical is looking for a Senior Pharmacovigilance Executive to join a large pharmaceutical company in Buckinghamshire.

The job:

As a Senior Pharmacovigilance Executive will work within the Medical Affairs Department and report to the Medical Affairs Manager. The main focus of your role would be to maintain and develop the drug safety processes, delivering a drug safety service for the company’s UK licensed and investigational products. One of the main challenges in this role would be to coordinate multiple tasks with tight deadlines. You will have proven Drug Safety experience with a life science degree.

Key responsibilities:

As a Senior Pharmacovigilance Executive your key responsibilities will be to: 

  • Perform the activities detailed in the Pharmacovigilance Agreement between Drug Safety Department, Head Office and the UK office
  • Your duties will include handling of individual case safety reports (ICSRs), implementing the UK quality system, carrying out literature searches as required
  • You will be doing training, compliance reporting, reviewing external agreements relating to drug safety and notifying updates to company core safety information
  • Ensure the accurate entry of drug safety case data arising from spontaneous or clinical trial reports
  • Liaise with the UK Medical Information personnel (or contractors) and Clinical Research personnel, external healthcare professionals, consumers or the MHRA to obtain available drug safety case information
  • Ensure that individual and aggregated safety reports are submitted within the required timelines to the relevant recipients and that a record of reporting compliance is forwarded to the QPPV as detailed in the Pharmacovigilance Agreement
  • Keep up-to-date with changes and developments in pharmacovigilance legislation and guidelines and the company’s internal procedures
  • Ensure that drug safety processes in the UK meet the current requirements for good pharmacovigilance practice
  • Develop and deliver drug safety training programmes relevant to all UK personnel who may be in receipt of drug safety information or perform functions related to drug safety.
  • Keep a record of drug safety training carried out by UK personnel and ensure that repeat or updated training is carried out at appropriate intervals
  • Maintain electronic and paper filing and archiving system suitable for the storage of source documents relating to drug safety case records
  • Foster good relations with Drug Safety personnel at Head Office

Qualifications & Experience:

The successful candidate for this Senior Pharmacovigilance Executive role will have the following qualifications and skills:

  • Life science, Healthcare degree, Pharmacist or Nurse
  • You must be a natural team player with the personal qualities to relate well to people at all levels.
  • Proven relevant industry experience within pharmacovigilance /drug safety

How to apply:

Apply online now

For more information or to apply for this Senior Pharmacovigilance Executive role please contact Hendre Moolman on 01438 870 023 or email hmoolman@ckclinical.co.uk.  Please quote reference CL24169 in all correspondence

Are you looking for a new job in the pharmaceutical industry? Click here to see our latest pharmacovigilance jobs.

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Clinical Data Scientist – South East

Priya Mukherjee at CK Clinical is currently recruiting for a Project Data Manager to work for a global Pharmaceutical company in the South-East.

Responsibilities:

The main responsibilities for this Project Data Manager/ Clinical Data Scientist role will include:

  • Work with Study Team members to assist in management of overall study data quality and integrity.
  • Responsible for coordination of data processing work done at offshore.
  • Perform eCRF data validation to ensure data integrity and quality including raising and resolving data queries.
  • Load, validate and reconcile vendor data including scans and biomarker data.
  • Work closely with colleagues and senior staff to assure consistency and accuracy of the database.
  • Effectively communicate with colleagues and customers to maintain a consistent approach to work.

Qualifications and skills:

Interested applicants for this Project Data Manager/ Clinical Data Scientist role will have a BSc (OR Equivalent) in a Life Sciences discipline together with:

  • Effective project/time management skills
  • Effective communication skills
  • Experience of working in EDC systems, ideally InForm
  • Experience of working in multi-disciplinary teams
  • Sound knowledge of data management processes
  • Sound knowledge of clinical development process
  • Experience of managing external/non CRF data from External vendors
  • Flexibility, a positive and pro-active attitude and excellent team player skills are all essential.
  • Oncology data management, local and central lab validation experience is also preferred.

How to apply:

Apply online now

For more information or to apply for this Project Data Manager/ Clinical Data Scientist role please contact Priya Mukherjee at CK Clinical on 01438 743 047 or email pmukherjee@ckclinical.co.uk. Please quote reference CL24166 in all correspondence.

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